FDA Inspection 1254196 — FALCON SYSTEM OF AYURVEDIC PRODUCTS
The FDA completed an inspection of FALCON SYSTEM OF AYURVEDIC PRODUCTS on November 13, 2024 in Belgaum. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 13, 2024
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Belgaum (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 15466 | 21 CFR 111.20(c) | Physical plant - proper precautions to prevent mix-ups, contamination |
| 15521 | 21 CFR 111.27(d)(6) | Cleaning compounds - adequate, safe |
| 15578 | 21 CFR 111.155(c) | Components - quarantine |
| 15589 | 21 CFR 111.160(c) | Packaging, labels - quarantine |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |
| 15939 | 21 CFR 111.105(g) | Quality control - reserve samples |
| 18154 | 21 CFR 117.80(a)(2) | Appropriate quality control operations |
| 18157 | 21 CFR 117.80(b)(2) | Raw materials control - Microorganisms |
| 22859 | 21 CFR 111.103 | Written procedures - establish; quality control operations |